HealthyNCT07194720
Effects of the Cornelian Cherry Supplementation on the Selected Physiological Parameters in Marathon Runners
A study testing Cornus mas lyophilisate in people with Healthy, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
Growing body of evidence indicates favorable effects of Cornus mas (Cornelian cherry) supplements on cardiometabolic risk, including the improvement of HDL and glycemic indices, in line with vascular benefits. Read more about this study
- Who is it for?
- Ages 45 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cornus mas lyophilisate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 sitePoland
- Study dates
- 15 Sep 2021to 21 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age above 45 years
Who cannot join
- chronic disease of the nervous, cardiovascular or respiratory system
- disease of the digestive system, including history of the intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance and other malabsorption disorders
- blood pressure-lowering treatment within the past year
- tobacco smoking within the past year
- antibiotic/probiotic treatment and laxative/prokinetic usage in three months preceding the anticipated enrollment
Trial locations and contacts
1 site in 1 country.
Poland1 site
Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, 50-376
About this study
Official title: Effects of the Cornelian Cherry (Cornus Mas L.) Lyophilisate Supplementation on the Selected Physiological Parameters in Amateur Long-Distance Runners
Growing body of evidence indicates favorable effects of Cornus mas (Cornelian cherry) supplements on cardiometabolic risk, including the improvement of HDL and glycemic indices, in line with vascular benefits. Experimental data feature bioactives from Cornelian cherry as potential modulators of vascular function and blood pressure, plausibly via endothelial nitric oxide-related pathways, with possible downstream effects on autonomic reflex control; nevertheless, such links in humans remain poorly explored to date, especially in terms of endurance training and hypoxia tolerance.
In this cross-over, placebo-controlled study, a group of healthy amateur long-distance runners underwent two stages of a four-week dietary intervention (separated by four weeks of washout period), receiving Cornelian cherry lyophilisate or placebo. Each supplementation stage was accompanied by the comprehensive evaluation of the cardio-respiratory parameters and endothelial function.
- Conditions
- Healthy
- Being tested
- Cornus mas lyophilisate, Placebo
- Keywords
- Cornus mas L., systemic vascular resistance, peripheral chemoreflex, endurance training, nitric oxide, endothelium, autonomic nervous system, blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cornus mas lyophilisateDietary supplement
Participants receiving a Cornus mas (Cornelian cherry) lyophilisate for 4 weeks.
PlaceboDietary supplement
Participants receiving a starch- and sugar-based placebo for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cornus mas lyophilisate | Experimental | Not described Receives: Dietary Supplement: Cornus mas lyophilisate |
| placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic vascular resistance
Resting systemic vascular resistance, evaluated non-invasively with a finger cuff-based device.
Measured: From the beginning to the end of a supplementation period at 4 weeks.
Office blood pressure values (mean, systolic, diastolic)
Resting arterial blood pressure values (mean, systolic, diastolic), measured continuously with a non-invasive, finger cuff-based device.
Measured: From the beginning to the end of a supplementation period at 4 weeks.
Secondary outcomes (2)
Peripheral chemoreflex sensitivity
Peripheral chemoreflex sensitivity, measured with the transient hypoxia test.
Measured: From the beginning to the end of a supplementation period at 4 weeks.
eNOS expression
Endothelial nitric oxide synthase expression, evaluated in the peripheral blood samples.
Measured: From the beginning to the end of a supplementation period at 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start15 Sep 2021
- Primary completion21 Apr 2022
- Study completion21 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw University of Environmental and Life Sciences
- Responsible party
- Principal investigator, Rafał Seredyński, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194720
- Sponsor's protocol ID
- DEREN.23.25
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small trial which includes solely healthy volunteers. Therefore, data will not be shared at this instance.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Cornelian Cherry (Cornus Mas L.) Lyophilisate Supplementation on the Selected Physiological Parameters in Amateur Long-Distance Runners
- ClinicalTrials.gov ID
- NCT07194720
- Acronym / sponsor ID
- DEREN.23.25
- Conditions
- Healthy
- Keywords
- Cornus mas L., systemic vascular resistance, peripheral chemoreflex, endurance training, nitric oxide, endothelium, autonomic nervous system, blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Collaborators
- Wroclaw University of Environmental and Life Sciences
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 21 Apr 2022 (actual)
- Study completion
- 21 Apr 2022 (actual)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Growing body of evidence indicates favorable effects of Cornus mas (Cornelian cherry) supplements on cardiometabolic risk, including the improvement of HDL and glycemic indices, in line with vascular benefits. Experimental data feature bioactives from Cornelian cherry as potential modulators of vascular function and blood pressure, plausibly via endothelial nitric oxide-related pathways, with possible downstream effects on autonomic reflex control; nevertheless, such links in humans remain poorly explored to date, especially in terms of endurance training and hypoxia tolerance.
In this cross-over, placebo-controlled study, a group of healthy amateur long-distance runners underwent two stages of a four-week dietary intervention (separated by four weeks of washout period), receiving Cornelian cherry lyophilisate or placebo. Each supplementation stage was accompanied by the comprehensive evaluation of the cardio-respiratory parameters and endothelial function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cornus mas lyophilisate | Experimental | Dietary Supplement: Cornus mas lyophilisate |
| placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age above 45 years
Key exclusion criteria (5 listed)
- chronic disease of the nervous, cardiovascular or respiratory system
- disease of the digestive system, including history of the intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance and other malabsorption disorders
- blood pressure-lowering treatment within the past year
- tobacco smoking within the past year
- antibiotic/probiotic treatment and laxative/prokinetic usage in three months preceding the anticipated enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cornus mas lyophilisateParticipants receiving a Cornus mas (Cornelian cherry) lyophilisate for 4 weeks. | Dietary supplement | Cornus mas lyophilisate |
| PlaceboParticipants receiving a starch- and sugar-based placebo for 4 weeks. | Dietary supplement | placebo |
Primary outcome
Systemic vascular resistance
Time frame: From the beginning to the end of a supplementation period at 4 weeks.
Resting systemic vascular resistance, evaluated non-invasively with a finger cuff-based device.
Office blood pressure values (mean, systolic, diastolic)
Time frame: From the beginning to the end of a supplementation period at 4 weeks.
Resting arterial blood pressure values (mean, systolic, diastolic), measured continuously with a non-invasive, finger cuff-based device.
2 secondary outcomes
Peripheral chemoreflex sensitivity
Time frame: From the beginning to the end of a supplementation period at 4 weeks.
eNOS expression
Time frame: From the beginning to the end of a supplementation period at 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No. This is a small trial which includes solely healthy volunteers. Therefore, data will not be shared at this instance.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cornus mas lyophilisate in people with Healthy, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic vascular resistance (time frame: From the beginning to the end of a supplementation period at 4 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.